510(k) K043084
- Device
- PREMERE DELIVERY SHEATH, MODEL PDS
- Applicant
- VELOCIMED INC.
- 510(k) number
- K043084
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-05-02
- Date received
- 2004-11-08
- Regulation
- 870.1340
- Classification name
- Introducer, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN CARLINE
- Address
- 6550 Wedgwood Rd. N. Suite 150 Maple Grove MN US 55311 55311
FDA Registration Numbers#
- 3005580113
- 1721686
- 1222140
- 3037047821
- 1000121056
- 3031571797
- 3035111606
- 3020347218
- 1313046
- 1625685
- 1423507
- 3010041511
- 3005168196
- 3011396687
- 3010419931
- 3009905888
- 1721676
- 3008328690
- 2134244
- 3005232773
- 3015970743
- 3017567825
- 3009746061
- 9614279
- 3031282706
- 2183870
- 1828424
- 1319639
- 1644312
- 3020283264
- 2953200
- 3006425876
- 3013666336
- 1123137
- 1835568
- 2246552
- 3039454510
- 3016591327
- 1928237
- 3011623145
- 3013162291
- 1921846
- 3007207906
- 3013986346
- 2523676
- 3019751610
- 3015225571
- 1724474
- 3010155661
- 3011642792
- 1424263
- 3016678045
- 8020785
- 2182269
- 3010220595
- 1423537
- 3003898360
- 3021951050
- 3000268902
- 3011024991
- 3004134316
- 1721504
- 3014656749
- 3017060084
- 3025028711
- 3002807314
- 2030404
- 9616099
- 9680794
- 3002601200
- 3007695959
- 3015138222
- 9681477
- 2011171
- 1118880
- 1018233
- 3016904853
- 3015309643
- 3003915875
- 8043892
Source Documents#
Other 510(k) Records For Product Code DYB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253526 | NAMIC Dilator and Sheath | Medline Industries, LP | 2026-07-29 |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | Hartman Medical Group, LLC | 2026-07-06 |
| K261242 | SimplGuide | Pendracare | 2026-06-25 |
| K261950 | Health Line Tearaway Introducer | Health Line International Corporation | 2026-06-22 |
| K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | 2026-06-05 |
| K260606 | Echo Large Bore Introducer Sheath | Echo Medical, LLC | 2026-04-29 |
| K254248 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | 2026-04-23 |
| K254279 | Edwards eSheath+ introducer set | Edwards Lifesciences | 2026-04-17 |
| K260091 | Aventus Introducer Sheath | Inquis Medical | 2026-04-13 |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | 2026-04-10 |
| K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2026-04-07 |
| K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | 2026-04-06 |
| K260626 | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | 2026-03-26 |
| K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | 2026-02-19 |
| K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | 2026-02-09 |
Legacy Summary#
summary
FDA Review#
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